The Validation Process
There are three stages of the Validation Process that will help to make sure that your product, process, service, or system meets industry requirements, user specifications, and is able to fulfill its intended purpose.
This first step in the validation process is completing the Installation Qualification (IQ):
Mesa's Compliance & Validation Services IQ protocols will:
- Record critical information applicable to the equipment, such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and the location where the equipment will be installed.
- Record the critical instrument and valve information, including the manufacturer, model number, materials of construction, and calibration information.
- Verify the required utilities for the equipment, such as electrical, process gases, water, or steam.
- Verify equipment documentation, such as P&IDs, Operation and Maintenance manuals, purchase orders, user requirements or specifications, and/or the necessary spare parts for the equipment.
The next phase in the validation process is completing the Operational Qualification (OQ):
Mesa's Compliance & Validation Services OQ protocols will:
- Verify that Standard Operating Procedures are available for the operation, maintenance, cleaning, or sterilization of the equipment.
- Document that the equipment operates as needed when used under normal conditions.
- Test the functionality of security systems, all of the operating modes that will be used by the equipment, alarms and interlocks, and any other functions of the equipment.
The final stage in the validation process is completing the Performance Qualification (PQ):
Mesa's Compliance & Validation Services PQ protocols are designed to:
- Verify that the equipment is able to consistently perform in accordance with your requirements and the equipment’s specifications.
- Verify that the equipment can operate consistently and repeatedly under normal, suboptimal, or worst case conditions.